(77 days)
Patients wishing to acquire, display and transmit their vital signs to a medical professional via Web-based Call Center for analysis and obtain response
Physicians for medical testing of patients' vital signs, display and analysis as well as follow up and response to patient's transmitted data
Not Found
The provided text is a 510(k) clearance letter from the FDA for a medical device. It does not contain specific information about:
- Acceptance criteria and device performance in a table format.
- Details of a study conducted to prove the device meets acceptance criteria (like sample sizes, data provenance, expert qualifications, or adjudication methods).
- Information about multi-reader multi-case comparative effectiveness studies or standalone algorithm performance.
- Type of ground truth used or training set details.
The letter primarily confirms that the device, CG-500 PMP4 Personal Medical Phone System, is substantially equivalent to legally marketed predicate devices. It discusses regulatory classifications, general controls, and directs the applicant to comply with various regulations, but it does not describe the technical performance evaluation of the device.
Therefore,Based on the provided document, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, ground truth, and training set information is not available. The document is a 510(k) clearance letter, which affirms that the device is substantially equivalent to a predicate device, but it does not contain the detailed study results or design elements that would describe how that substantial equivalence was demonstrated in terms of performance metrics.
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Public Health Service
Image /page/0/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name arranged in a circular pattern around a central emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and a staff.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 7 2003
Card Guard Scientific Survival Ltd. c/o Mr. Alex Gonorovsky Regulatory Affairs, QA 2 Pekeris St., P.O. Box 527 Rehovot 76101 Israel
Re: K023689
Trade Name: CG-500 PMP4 Personal Medical Phone System Regulation Number: 21 CFR 870.2920 Regulation Name: Telephone Electrocardiograph Transmitter and Receiver Regulatory Class: Class II (two) Product Code: DXH Dated: September 15, 2002 Received: November 1, 2002
Dear Mr. Gonorovsky:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Alex Gonorovsky
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
V. Walter Tull
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/2/Figure/0 description: The image shows the logo for Card Guard Scientific Survival LTD. The logo is in black and white and features the words "CARD GUARD" in bold letters above the words "Scientific Survival LTD." There is a line above the words "Scientific Survival LTD." To the right of the words is a line that resembles an EKG.
510(k) Number (if known):
The CG-500 PMP4 portable Personal Medical Phone System is intended for:
Patients wishing to acquire, display and transmit their vital signs to a medical a) professional via Web-based Call Center for analysis and obtain response
b) Physicians for medical testing of patients' vital signs, display and analysis as well as follow up and response to patient's transmitted data
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ✔ OR (Per 21 CFR 801.109) (Optional Format 1-2-96)
Over-The-Counter Use
17
N. Dege Tu
510(k) Numbe
§ 870.2920 Telephone electrocardiograph transmitter and receiver.
(a)
Identification. A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.(b)
Classification. Class II (performance standards).